A prospective randomized study on patients with late in the bag intraocular lens (IOL) dislocation after cataract surgery. Two surgical techniques of suturing of IOL to the sclera will be compared in the study. IOL position will be compared between those two groups, as well to a control group consisting of ordinary pseudophakia where only measurement of IOL position will be performed.
In this prospective randomized study 60 patients will be included with late intraocular lens (IOL) dislocation and 60 patients in a control group with ordinary pseudophakia. Traditional surgery includes a capsular-IOL complex fixation to sclera by looping a prolene suture not only around haptics but also through capsular tissue. Such a suture may cut through the bag, which may result in a decentered IOL. A modification of "the traditional" method was created at S:t Eriks Eye Hospital in order to achieve better centration of the IOL. The study will evaluate the efficacy of these two methods. Additionally, the impact of fibrosis of capsular bag on IOL stability postoperatively will be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
117
traditional IOL scleral suture fixation
Modified IOL scleral suture fixation
Laura Armonaite
Stockholm, Sweden
IOL position
Measured at 3 time points: 1 month, 6 months and 1.5 years postoperatively, with anterior optical coherence tomography (OCT).
Time frame: through study completion, an average of 1,5 years
Capsular thickness
Measured with OCT and photographed on slit-lamp examination.
Time frame: preoperatively or as soon as possible postoperatively
Astigmatism
Measured with corneal topography, autorefractometer and keratometer. Corneal and IOL related astigmatism measured in diopters.Measured at 3 time points: 1 month, 6 months and 1.5 years postoperatively,
Time frame: through study completion, an average of 1,5 years
Best Corrected Visual Acuity (BCVA)
Measure for visual function. Measured in logMAR. Measured preoperatively, 1 month, 6 months and 1.5 years postoperatively
Time frame: through study completion, an average of 1,5 years
Intraocular Pressure (IOP)
Measure for the pressure inside the eye measured with Goldman applanation tonometer and iCare, both in mmHg. Measured preoperatively, 1 month, 6 months and 1.5 years postoperatively
Time frame: through study completion, an average of 1,5 years
administration of IOL lowering therapy
number of patients who used IOL lowering therapy
Time frame: through study completion, an average of 1,5 years
Number of participants with postoperative complications
Number of patients with retinal detachment, macular edema and other.
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Time frame: through study completion, an average of 1,5 year
Precision of the IOL position measurement with OCT
Measurements of IOL position with OCT will be done 3 times by the same investigator in both mydriatic and non-mydriatic pupil status.
Time frame: 1 month or any other postoperative control through study completion, an average of 1,5 year
inflammation in anterior chamber
Measured at 2 time points: 6 months and 1.5 years postoperatively, with laser flare meter.
Time frame: through study completion, an average of 1,5 years